Malfeasance is when a public official violates the public trust by performing an act that is wrongful, legally unjustified, or contrary to law. Nonfeasance is the failure to act where there is a duty to act. Misfeasance is conduct that is lawful but inappropriate. Perhaps, when it comes to the recent approval of Gardasil 9 all of these apply.
10 December 2014: The FDA approved the use of a reportedly “new and improved” version of Gardasil, which will be marketed as Gardasil 9. According to the FDA approval letter, this action was taken without consultation with VRBPAC (the Vaccines and Related Biological Products Advisory Committee) which is responsible for reviewing and evaluating data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products.
The FDA approval letter, signed by Marion Gruber, Director of Office of Vaccines Research and Review CBER, states the reason for bypassing the advice of VRBPAC writing:
”We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.”
So, the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER) committee took it upon themselves to decide there were ”no concerns or controversial issues” regarding the approval of Gardasil 9?
This division of CBER decided there would be no benefit from ”an advisory committee discussion”?
According to their own mission statement, the FDA is ”responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”
The FDA, and all committees associated with the FDA, are public officials and therefore obliged to act in the public’s best interest particularly when it comes to health and safety issues.
Is bypassing advisory committee discussions regarding Gardasil 9’s potential safety and efficacy acting in the public’s best interest, or is it malfeasance, nonfeasance and/or misfeasance?
Gardasil 9 Facts: More than DOUBLE the amount of Toxic Aluminum!
CBER decided there was no need for VRBPAC to review or evaluate any data concerning the safety, effectiveness, and appropriate use of Merck’s proposed Gardasil 9 vaccine before making a decision to approve the nine-valent HPV vaccine. This move is particularly disturbing when one considers the worldwide controversy surrounding Gardasil’s safety, effectiveness and appropriate use.
The proposed Gardasil 9 package insert and the current Gardasil package insert are a good place to start a critical examination. The table below lists the ingredients of both Gardasil and Gardasil 9. All differences from one HPV vaccine package insert to the next are highlighted.
Read More: Here